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Submission status for DELCATH SYSTEMS INC's drug HEPZATO (SUPPL-18) with active ingredient MELPHALAN HYDROCHLORIDE has changed to 'Approval' on 08/12/2026. Application Category: NDA, Application Number: 201848, Application Classification: REMS
Submission status for LEXICON PHARMS INC's drug INPEFA (SUPPL-3) with active ingredient SOTAGLIFLOZIN has changed to 'Approval' on 08/06/2026. Application Category: NDA, Application Number: 216203, Application Classification: Labeling
Submission status for GILEAD SCIENCES INC's drug VEKLURY (SUPPL-33) with active ingredient REMDESIVIR has changed to 'Approval' on 07/29/2026. Application Category: NDA, Application Number: 214787, Application Classification: Labeling
Submission status for VANDA PHARMS INC's drug HETLIOZ (SUPPL-13) with active ingredient TASIMELTEON has changed to 'Approval' on 07/27/2026. Application Category: NDA, Application Number: 205677, Application Classification: Manufacturing (CMC)
Submission status for OUTLOOK THERAPEUTICS, INC.'s drug LYTENAVA (ORIG-1) with active ingredient BEVACIZUMAB-VIKG has changed to 'Approval' on 07/24/2026. Application Category: BLA, Application Number: 761320, Application Classification:
Submission status for SANOFI AVENTIS US's drug AVAPRO (SUPPL-81) with active ingredient IRBESARTAN has changed to 'Approval' on 07/24/2026. Application Category: NDA, Application Number: 020757, Application Classification: Labeling
Submission status for NUVALENT INC's drug JIDEYTRO (ORIG-1) with active ingredient ZIDESAMTINIB has changed to 'Approval' on 07/22/2026. Application Category: NDA, Application Number: 220185, Application Classification: Type 1 - New Molecular Entity
Submission status for LANNETT CO INC's drug METHADONE HYDROCHLORIDE (SUPPL-1) with active ingredient METHADONE HYDROCHLORIDE has changed to 'Approval' on 07/17/2026. Application Category: ANDA, Application Number: 212093, Application Classification: Labeling
Submission status for LANNETT CO INC's drug METHADONE HYDROCHLORIDE (SUPPL-7) with active ingredient METHADONE HYDROCHLORIDE has changed to 'Approval' on 07/17/2026. Application Category: ANDA, Application Number: 212093, Application Classification: Labeling
Submission status for LANNETT CO INC's drug METHADONE HYDROCHLORIDE (SUPPL-2) with active ingredient METHADONE HYDROCHLORIDE has changed to 'Approval' on 07/17/2026. Application Category: ANDA, Application Number: 212093, Application Classification: Labeling
Submission status for LANNETT CO INC's drug METHADONE HYDROCHLORIDE (SUPPL-6) with active ingredient METHADONE HYDROCHLORIDE has changed to 'Approval' on 07/17/2026. Application Category: ANDA, Application Number: 212093, Application Classification: Labeling
Submission status for CELCUITY INC..'s drug REVTORPYK (ORIG-1) with active ingredient GEDATOLISIB has changed to 'Approval' on 07/14/2026. Application Category: NDA, Application Number: 219908, Application Classification: Type 1 - New Molecular Entity
Submission status for AMGEN INC's drug REPATHA (SUPPL-49) with active ingredient EVOLOCUMAB has changed to 'Approval' on 07/15/2026. Application Category: BLA, Application Number: 125522, Application Classification:
Submission status for SANOFI-AVENTIS U.S. LLC's drug SARCLISA ESCENA (ORIG-1) with active ingredient ISATUXIMAB-IRFC has changed to 'Approval' on 07/09/2026. Application Category: BLA, Application Number: 761445, Application Classification:
Submission status for VERA THERAPEUTICS INC.'s drug TRUTAKNA (ORIG-1) with active ingredient ATACIEPT-VYMJ has changed to 'Approval' on 07/07/2026. Application Category: BLA, Application Number: 761486, Application Classification:
Submission status for VIRIDIAN THERAPEUTICS INC's drug LUMVOA (ORIG-1) with active ingredient VELIGROTUG-VVZE has changed to 'Approval' on 06/26/2026. Application Category: BLA, Application Number: 761530, Application Classification:
Submission status for INSMED INC's drug ARIKAYCE KIT (SUPPL-25) with active ingredient AMIKACIN SULFATE has changed to 'Approval' on 06/25/2026. Application Category: NDA, Application Number: 207356, Application Classification: Labeling
Submission status for ABBVIE INC's drug SKYRIZI (SUPPL-16) with active ingredient RISANKIZUMAB-RZAA has changed to 'Approval' on 06/26/2026. Application Category: BLA, Application Number: 761262, Application Classification:
Submission status for SANOFI AVENTIS US's drug SARCLISA (SUPPL-18) with active ingredient ISATUXIMAB-IRFC has changed to 'Approval' on 06/26/2026. Application Category: BLA, Application Number: 761113, Application Classification:
Submission status for ABBVIE INC's drug SKYRIZI (SUPPL-45) with active ingredient RISANKIZUMAB-RZAA has changed to 'Approval' on 06/26/2026. Application Category: BLA, Application Number: 761105, Application Classification:
